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510(k) K822709

Device
URITEST 9, INLAB REAGENT STRIPS URINALY
Applicant
LAPROL SCIENTIFIC, INC.
510(k) number
K822709
Product code
JMA  
Decision
Substantially Equivalent (SESE)
Decision date
1983-01-28
Date received
1982-09-07
Regulation
862.1095
Classification name
Acid, Ascorbic, 2,4-dinitrophenylhydrazine (spectrophotometric)
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JMA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K931523QUANTIMETRIX C-CLEAR(TM)Quantimetrix Corp.1993-06-25
K830978HELENA BIOSTRIP AHelena Laboratories1983-05-13

Legacy Summary#

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FDA Review#

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